The landscape of clinical research in the United States faces unprecedented challenges following the Supreme Court's Dobbs decision, as restrictive state abortion laws create far-reaching implications for trial participation among women of reproductive age.
Legal experts warn that broadly written state abortion laws could have unintended consequences for clinical research, potentially deterring both sponsors and participants. Allison Whelan, assistant professor at Georgia State University College of Law, highlights how state laws could be interpreted to expose trial sponsors to legal risks, even when providing standard trial-related information about pregnancy and abortion.
Legal Risks and Privacy Concerns
The current legal framework presents multiple challenges for clinical trial operations. States with restrictive abortion laws could potentially prosecute pregnant participants under child neglect or "chemical endangerment" laws for exposure to investigational drugs. Trial sponsors must now navigate complex informed consent processes that address not only medical risks but also potential legal consequences.
"There aren't any states that have gone so far as to explicitly criminalize the pregnant person who receives an abortion," Whelan explains, "but there are ways that states can, and have, prosecuted people for actions during pregnancy that harm a fetus or end a pregnancy."
Impact on Trial Design and Participation
Standard clinical trial procedures, such as routine pregnancy testing, have taken on new complexity in the post-Dobbs environment. These tests could potentially document early pregnancies that might otherwise go unnoticed, creating records that could be subject to legal scrutiny in certain jurisdictions.
The situation particularly affects trials requiring participants to avoid pregnancy during the study period. As Whelan notes, "If a person becomes pregnant during this trial, and they want to remain in this trial, the only real way for them to do so is to terminate their pregnancy." This creates significant challenges in states with restrictive abortion laws.
Broader Implications for Medical Research
The impact extends beyond reproductive health studies. Research into new applications for drugs like mifepristone, which has shown promise in treating conditions such as Cushing's syndrome and PTSD, could face additional scrutiny and funding challenges due to the medication's association with abortion care.
Mitigation Strategies and Future Considerations
Clinical trial sponsors are advised to implement robust confidentiality measures, including obtaining certificates of confidentiality whenever possible. However, Whelan cautions that even these protections are not absolute under current state laws.
The situation creates a potential setback for recent progress in clinical trial diversity and inclusion. While global health organizations, including the World Health Organization, advocate for increased participation of pregnant and lactating women in clinical trials, US abortion laws could effectively counter these efforts.
Industry Response and Path Forward
Pharmaceutical companies and research institutions must balance scientific advancement with legal compliance in this new regulatory environment. Some sponsors may opt to concentrate trials in states with stronger reproductive rights protections, though this approach could limit access for participants in restrictive states, particularly affecting rare disease research where patient populations are already limited.
The pharmaceutical industry, with its significant economic and political influence, may need to take a more active role in advocating for clearer legal frameworks that protect both research participants and scientific progress. The current situation threatens to undermine decades of progress in promoting diverse representation in clinical trials and advancing medical research for all populations.
